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Showing 15 posts of 1442 posts found.

FDA grants accelerated approval to Pfizer’s Elrexfio

August 15, 2023
Medical Communications Elrexfio, FDA, Oncology, Pfizer, accelerated approval

Pfizer has that the US Food and Drug Administration (FDA) has granted accelerated approval to Elrexfio (elranatamab-bcmm) for the treatment …

News
lungs

FDA grants orphan drug designation to Genprex’s Reqorsa

August 15, 2023
Medical Communications FDA, ODD, Oncology, Reqorsa

Gene therapy company Genprex has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) …

News

FDA approved Janssen’s Akeega for prostate cancer treatment

August 14, 2023
Research and Development Akeega, FDA, J&J, Janssen, Oncology, prostate cancer

The Janssen Pharmaceutical companies of Johnson & Johnson have announced that the US Food and Drug Administration (FDA) has approved …

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pawel-czerwinski-2y8ol_obs1i-unsplash_2

FDA approves Talvey for the treatment of heavily pretreated multiple myeloma

August 11, 2023
Medical Communications FDA, J&J, Janssen, Oncology, Talvey, multiple myeloma

The Janssen Pharmaceutical companies of Johnson & Johnson has announced that the US Food and Drug Administration (FDA) has granted …

News

FDA accepts Astellas’ sNDA for Cresemba in children

August 11, 2023
Research and Development Astella, FDA, Paediatrics, cresemba

The US Food and Drug Administration (FDA) announced it has accepted Astellas Pharma’s supplemental New Drug Application (sNDA) for Cresemba …

News

FDA grants clearance to next phase of Ascentage Pharma’s clinical trial for CLL/SLL treatment

August 8, 2023
Research and Development Ascentage Pharma, CLL/SLL, FDA, Oncology, clinical trial

Ascentage Pharma has announced that the US Food and Drug Administration (FDA) has granted clearance for the phase 3 study …

News

First oral treatment for women with postpartum depression approved by FDA

August 7, 2023
Research and Development FDA, postpartum depression, treatment, zurzuvae

On 4 August 2023, the US Food and Drug Administration (FDA) approved the use of Zurzuvae for adults with postpartum …

News
eye2

Astellas announces FDA approval for Izervay for GA treatment

August 7, 2023
Medical Communications AMD, Astellas Pharma, FDA, Izervay, Opthalmology, geographic atrophy

Astellas Pharma has announced that the US Food and Drug Administration (FDA) has approved Izervay (avacincaptag pegol intravitreal solution) for …

News

FDA approves Merck’s Ervebo vaccine for under 18s

August 4, 2023
Research and Development FDA, Immunology, Vaccine, ebolavirus

On 3 August 2023, the US Food and Drug Administration (FDA) approved Merck’s Ervebo vaccine for children over 12 months. …

News

FDA approves Taiho’s Lonsurf for metastatic colorectal cancer treatment

August 3, 2023
Medical Communications FDA, Lonsurf, Oncology, colorectal cancer, mCRC, taiho

Taiho Oncology and Taiho Pharmaceutical have announced that the US Food and Drug Administration (FDA) has approved Lonsurf (trifluridine/tipiracil) as …

News
Chemotherapy

FDA grants ODD to ABM Therapeutics’ treatment for patients with glioblastoma

August 3, 2023
Medical Communications ABM Therapeutics, ABM-1310, FDA, Oncology, glioblastoma

ABM Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABM-1310. …

News

GSK’s Jemperli approved for treatment of endometrial cancer

August 1, 2023
Research and Development FDA, GSK, Jemperli, Oncology, dostarlimab, endometrial cancer

GSK has announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and …

News

FDA approves a second OTC naloxone nasal spray

July 31, 2023
Medical Communications FDA, Nasal Spray, OTC, OTC Products, naloxone, opioids

The US Food and Drug Administration (FDA) has announced that it has approved RiVive, 3mg naloxone hydrochloride nasal spray for …

News
stethoscope_and_background_doctor

Aevice Health gains FDA clearance for respiratory monitoring platform

July 21, 2023
Research and Development Aevice Health, Devices, FDA, respiratory monitoring

Remote respiratory monitoring solutions company Aevice Health has announced that it has received clearance from the US Food and Drug …

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FDA approves AstraZeneca’s drug to prevent RSV in babies and young children

July 18, 2023
Research and Development AstraZeneca, FDA, Immunology, RSV, Vaccine, paediatrics

The US Food and Drug Administration (FDA) has announced that it has approved Beyfortus (nirsevimab-alip) for the prevention of respiratory …

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